Involuntary release of urine is a problem, particularly for aging men, when the sphincter muscles, at the base of the urethra as it exits the bladder, weaken as the result of disease progression, such as diabetes, or following a surgical procedure, such as transurethral bladder resection or radical prostatectomy. Complete lack of bladder control led to the invention of the Foley catheter, which is often used on a temporary basis when bladder control can be regained so that only minor intermittent leakage remains. However, weakening of control of the sphincter surrounding the urethra subjects the patient to, for example, stress incontinence from increased abdominal pressure resulting from a simple cough, or sneeze. Such leakage not only creates psychological distress but can also lead to skin or urinary tract infections. An increasing number of aging but active and mobile men, amounting to several million in the United States alone, have to deal with this problem and require an easy to use, economical and discreet solution, thereby creating a demand for a urinary incontinence device to handle mild to moderate incontinence.
A variety of approaches have attempted to meet these needs. Incontinence small pads, which make for additional protection and for better fit, being worn in an incontinence garment, are often used. Many incontinence products are modifications of existing products not suited for men or for a man's self-image, e.g., Depend® (Depend® is registered trademark of Kimberly-Clark, Inc. of Irving, Tex.) diapers or a male incontinence shield adapted from the female sanitary garment, which requires a man to apply a pad with an adhesive layer to their undergarment. While these pads may in many cases provide sufficient storage capacity, they seem more appropriate for the female anatomy than for the male anatomy. Either such a pad is pressed so tightly against the body, e.g., by an incontinence garment, such that wearing comfort is affected, or there is a risk of leakage. In particular, since the penis and thereby the urinary duct has some freedom to move, urine may be deposited towards the edge or even outside the pad. Male shields currently mirror female protective garments and do not take into account that the scrotum and testes are also in contact with this garment so such shields can contribute to, and have contributed to, impaired skin integrity, moreover, they are bulky and non-discreet. Depend® undergarments contribute to the psychological undermining and further emasculating of the man recovering from a temporary/permanent medical issue. Moreover, persons who have worn boxer undergarments all their adult life are now forced to change their lifestyle and purchase undergarments that they have never worn.
On the other hand, a condom catheter has a tendency to dislodge and an incontinence pouch constructed using a modified Cunningham hard plastic clip can only be used for 15 minutes at a time to avoid blood circulation blockage.
A number of devices have been proposed for urinary incontinence where some bladder control is retained. One proposed solution (“Urine absorbent pouch for male incontinence”, Lucas Bak Bindal, U.S. Patent Application Serial Number 2011/0015604A1, filed July/2007) is inconvenient as it requires the user to insert his penis through the moldable hole on one side of the flap, which adheres to the other side, then he must assemble the device in such a way that it stays in place, which assumes the penis does not retract. A second proposed solution (Lars Mattsson, “Male Incontinence Pouch”, U.S. Pat. No. 6,209,142, Issued April/2001), which can accommodate only the penis or the penis plus scrotum, has the possibility of leakage if the complicated seals on the upper section are not secured. A third proposed solution (John A. Rooyakkers, “Absorbent Genitalia Pouch for Incontinent Males, U.S. Pat. No. 4,772,280, Issued September/1988) is designed to accommodate both penis and scrotum; however, such an approach has the disadvantage of skin breakdown due to accumulating moisture thus creating a high potential for skin and scrotum sheer. Moreover, users mustwear tight undergarments or additional garments to keep the device in place but it could still move and not offer the anticipated level of urinary incontinence protection. A fourth approach (Edward E. Elson et. al., “Male Urinary Incontinence Sheath Having Gel Adhesive and Elastic Securement Tape”, U.S. Pat. No. 7,166,092, Granted Janurary/2007) is designed for heavy urinary incontinence with a connection adaptor able to attach to a leg bag (second urinary storage device) secured to the user's leg. The adhesive attached to the user's skin impairs the skin integrity with the resulting risk for infection. There is also a risk for urine backup from the air lock in the drain tube or from a dysfunctional coupler; moreover, there is a plastic device, which traps body heat thereby risking impaired skin integrity. A fifth approach (Achim Schmitt et. al, “Male Incontinence Device”, European Patent Office Patent Application Serial No. EP 1136051, filed March/2000) is designed to accommodate the entire male genitalia both scrotum and penis thereby exposing the scrotum to urine, which risks skin breaks and resulting infections. It is designed with three layers of protection, which may not be needed with the present availability of super absorbent material.
In general, there is an unmet need for a practical and efficient incontinence protection device designed for the male anatomy with a comfortable, secure fit designed for 24-hour protection; discreet outer appearance; a moisture lock barrier to protect against skin breakdown; and protection from scrotum sheer. The need is particularly great for men having undergone a prostatectomy for cancer or men with lower urinary tract symptoms, such as urgency and pre- and post-void urinary dribble, who are unable to make it to the bathroom in time.